1型糖尿病治療薬の世界市場予測および分析...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 11
1.1 List of Tables 16
1.2 List of Figures 21

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23

3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 26
3.1.3 Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes 27
3.2 Symptoms 28
3.3 Prognosis 29
3.4 Quality of Life 29

4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 32
4.3 Global Trends 34
4.3.1 US 34
4.3.2 5EU 35
4.3.3 Japan 35
4.3.4 Canada 36
4.4 Forecast Methodology 36
4.4.1 Sources Used 38
4.4.2 Sources Not Used 41
4.4.3 8MM, Forecast Assumptions and Methods – Diagnosed Prevalent Cases of Type 2 Diabetes in Persons Ages ≥20 Years 42
4.4.4 8MM, Forecast Assumptions and Methods – Diagnosed Prevalent Cases of Type 1 Diabetes 45
4.5 Epidemiological Forecast for Type 1 Diabetes (2013-2023) 51
4.5.1 Diagnosed Prevalent Cases of Type 1 Diabetes 51
4.5.2 Age-Specific Diagnosed Prevalent Cases of Type 1 Diabetes 52
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Type 1 Diabetes 54
4.5.4 Age-Standardized Diagnosed Prevalence of Type 1 Diabetes 56
4.5.5 Diagnosed Prevalent Cases of Type 1 Diabetes Segmented by Body Mass Index 58
4.6 Discussion 59
4.6.1 Epidemiological Forecast Insight 59
4.6.2 Limitations of the Analysis 59
4.6.3 Strengths of the Analysis 60

5 Disease Management 61
5.1 Diagnosis and Treatment Overview 61
5.1.1 Diagnosis 61
5.1.2 Treatment Guidelines and Leading Prescribed Therapies 63
5.1.3 Clinical Practice 65
5.2 US 70
5.3 France 74
5.4 Germany 77
5.5 Italy 80
5.6 Spain 83
5.7 UK 86
5.8 Japan 89
5.9 Canada 91

6 Competitive Assessment 94
6.1 Overview 94
6.2 Current Treatments 97
6.2.1 Human Insulins (Injectable Formulations) 97
6.2.2 Humalog (insulin lispro) 100
6.2.3 NovoLog/NovoRapid (insulin aspart) 106
6.2.4 Apidra (insulin glulisine) 112
6.2.5 Lantus (insulin glargine) 118
6.2.6 Levemir (insulin detemir) 125
6.2.7 Tresiba (insulin degludec) 130
6.2.8 Pancreas and Islet Cell Transplantation 137

7 Unmet Need and Opportunity 140
7.1 Overview 140
7.2 Disease-Modifying Treatment – Preservation of Beta Cells 141
7.2.1 Unmet Need 141
7.2.2 Gap Analysis 142
7.2.3 Opportunity 143
7.3 Hypoglycemia Avoidance 143
7.3.1 Unmet Need 143
7.3.2 Gap Analysis 144
7.3.3 Opportunity 145
7.4 Weight Loss and Control of Associated Metabolic Syndrome 145
7.4.1 Unmet Need 145
7.4.2 Gap Analysis 146
7.4.3 Opportunity 146
7.5 Treatment for Brittle Diabetes 147
7.5.1 Unmet Need 147
7.5.2 Gap Analysis 147
7.5.3 Opportunity 148
7.6 Increased Patient Adherence to Therapy 148
7.6.1 Unmet Need 148
7.6.2 Gap Analysis 149
7.6.3 Opportunity 149

8 Pipeline Assessment 150
8.1 Overview 150
8.2 Clinical Trial Mapping 152
8.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 152
8.3 Promising Drugs in Clinical Development 153
8.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 155
8.3.2 Novel Formulation of Insulin Glargine: Toujeo 160
8.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 165
8.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 171
8.3.5 Adjunct Therapies 177
8.4 Biosimilar Insulins 188
8.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 188
8.4.2 Biosimilar Insulins Pipeline 191
8.4.3 Forecast 192
8.5 Artificial Pancreas 194
8.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 195

9 Current and Future Players 201
9.1 Overview 201
9.2 Trends in Corporate Strategy 203
9.3 Company Profiles 204
9.3.1 Novo Nordisk 204
9.3.2 Sanofi 207
9.3.3 Eli Lilly 210

10 Market Outlook 214
10.1 Global Markets 214
10.1.1 Forecast 214
10.1.2 Drivers and Barriers – Global Issues 220
10.2 United States 222
10.2.1 Forecast 222
10.2.2 Key Events 227
10.2.3 Drivers and Barriers 227
10.3 5EU 230
10.3.1 Forecast 230
10.3.2 Key Events 235
10.3.3 Drivers and Barriers 236
10.4 Japan 240
10.4.1 Forecast 240
10.4.2 Key Events 245
10.4.3 Drivers and Barriers 245
10.5 Canada 247
10.5.1 Forecast 247
10.5.2 Key Events 252
10.5.3 Drivers and Barriers 252

11 Appendix 254
11.1 Bibliography 254
11.2 Abbreviations 270
11.3 Methodology 275
11.4 Forecasting Methodology 275
11.4.1 Diagnosed Type 1 Diabetes Patients 275
11.4.2 Percent Drug-Treated Patients 275
11.4.3 Drugs Included in Each Therapeutic Class 276
11.4.4 Launch and Patent Expiry Dates 276
11.4.5 General Pricing Assumptions 277
11.4.6 Individual Drug Assumptions 278
11.4.7 Pricing of Pipeline Agents 281
11.5 Physicians and Specialists Included in This Study 283
11.6 About the Authors 286
11.6.1 Author 286
11.6.2 Epidemiologist 286
11.6.3 Global Head of Healthcare 287
11.7 About GlobalData 288
11.8 Disclaimer 288